Mylan granted license to market generic menopause drug

PITTSBURGH — Mylan will begin selling a generic drug for treating symptoms of menopause in two years, the company said Monday.

Following the settlement of a patent-litigation suit with Swiss drug maker Novartis over the patch Vivelle-Dot (estradiol transdermal system), Mylan said it had received a patent license to begin selling its version of the drug in December 2013.

The Pittsburgh-based generic drug maker was the first to file for regulatory approval of the drug with the Food and Drug Administration, and as such, will be entitled to 180 days of market exclusivity in which to compete directly with the branded version, after which other generic companies will be able to make their own versions.

Vivelle-Dot had sales of $240 million during the 12-month period ended in September, according to IMS Health. The patch is designed to be applied twice a week, and Mylan plans to sell it in the 0.025 mg, 0.0375 mg, 0.05 mg, 0.075 mg and 0.1 mg strengths.

NACDS names Kathleen Jaeger SVP pharmacy care, patient advocacy

ALEXANDRIA, Va. — The National Association of Chain Drug Stores has appointed pharmacist and trade association veteran Kathleen Jaeger to fill the newly enhanced position of SVP pharmacy care and patient advocacy. She also will serve in a separate role as president of the NACDS Foundation.

Jaeger will assume her new positions on Nov. 28, and will report to NACDS president and CEO Steve Anderson.

“With 24 years of experience and leadership as a trade association CEO, pharmacist, attorney and advocate, Kathleen Jaeger will serve as a clear and compelling voice for the value of community pharmacy and for the needs of patients in this new and expanded role at NACDS,” Anderson stated.

“NACDS’ absolute commitment to telling the story of community pharmacies as the face of neighborhood health care has brought us to the point that pharmacy no longer is talking only to itself," Anderson continued. "We are raising awareness of the value of pharmacy among consumers and patients, among elected officials and policymakers, among the media and among all healthcare partners and stakeholders. Now, it is time to take this work to the next level of success.”

Previously, Jaeger has served as EVP and CEO of the National Community Pharmacists Association and as president and CEO of the Generic Pharmaceutical Association. She also has been a partner in the food and drug practices of national law firms Kirkpatrick & Lockhart and McKenna & Cuneo. She also has served as a hospital pharmacist at the National Institute of Health.

As NACDS’ SVP pharmacy care and patient advocacy, Jaeger will serve as a spokeswoman for pharmacy patient care before key constituencies and target audiences, including in the media and at public and healthcare events. She also will direct the staff of the newly renamed Pharmacy Care and Patient Advocacy Department, which advances pharmacy information and research, conducts outreach with NACDS members and with external constituencies, including colleges and schools of pharmacy, and provides pharmacy insights and expertise that contribute to NACDS’ public policy advocacy and communications initiatives.

“Every day, countless patient care success stories play out in pharmacies in neighborhoods across America. I look forward to helping to tell this story to advance patient care, and I look forward to doing so with the insights and true passion that flow from being a pharmacist and the daughter of a pharmacist," Jaeger stated. "It is a distinct honor to represent community pharmacy and the value that it delivers to patients and to the broader healthcare system."

FDA approves Eylea

SILVER SPRING, Md. — After being unanimously recommended for approval by a Food and Drug Administration panel, the FDA has approved an eye disorder treatment created by Regeneron Pharmaceuticals.

The FDA on Friday approved Eylea (aflibercept) to treat patients with wet age-related macular degeneration, a leading cause of vision loss and blindness. The wet form of AMD includes the growth of abnormal blood vessels, which can leak fluid into the central part of the retina, also known as the macula. When fluid leaks into the macula, the macula thickens and vision loss occurs. An early symptom of wet AMD occurs when straight lines appear to be wavy, the FDA noted.

The drug was recommended for approval back in June by the Dermatologic and Ophthalmic Drugs Advisory Committee.

"Eylea is an important new treatment option for adults with wet AMD," said Edward Cox, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research. "It is a potentially blinding disease and the availability of new treatment options is important."

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